Our qualified consulting group has deep experience with study design including endpoint selection, estimand structure, powering, interim analyses, overall development plans and can provide input on innovative designs and create simulations. The Altru team has extensive experience across therapeutic areas including representation during FDA interactions (in-person, written or TCON) as well as with other regulatory bodies across the globe. Whatever your needs are, the team at Altru Clinical Research is ready and well-equipped to assist with your project.